FDA WARNING_LETTER - Local Legends Distribution LLC - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Harrison Haugland regarding e-liquid products sold on locallegendsatx.com. The FDA determined that "Key Lime Pie 60ml" and "Magic Mango 60ml" e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these e-liquid products are being manufactured and offered for sale without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 470 products listed with FDA. A Premarket Tobacco Product Application (PMTA), STN PM0003670, submitted on September 9, 2020, covering 437 products, received a Marketing Denial Order on September 3, 2021.

The FDA emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement action, including